NCT02063815

Brief Summary

The purpose of this randomized clinical trial was to compare caries prevention of a conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and fissures over a one year period in a high caries children group. Additionally the concentration of Fluoride in saliva was evaluated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

2.7 years

First QC Date

February 13, 2014

Last Update Submit

February 13, 2014

Conditions

Caries PreventionFissure SealantFluoride ConcentrationGlass Ionomer CementResin

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Fluoride concentration of saliva

    1 week, 6. months, 12. months

Study Arms (2)

glass ionomer based fissure sealant

ACTIVE COMPARATOR

fissure sealant application

Procedure: Fissure sealant application

resin based fissure sealant

ACTIVE COMPARATOR

fissure sealant application

Procedure: Fissure sealant application

Interventions

Fissure sealant applicationPROCEDURE
glass ionomer based fissure sealantresin based fissure sealant

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age range of 6 to 10 years 2.Having caries free, fully erupted first permanent molars 3.Deep and/or intermediate pits or fissures 4.dft ≥ 2

You may not qualify if:

  • Having any systemic disease 2.Topical fluoride was applied last six months 3.dft = 0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

June 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02